Treatment of Non-alcoholic Steatohepatitis (NASH) Patients With Vitamin D

NCT01571063 | Completed Phase 2

• 1 other identifier: SASL 34
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

Test the efficacy of vitamin D to improve non-alcoholic steatohepatitis with regard to biochemical and histological parameters.

• Trial with medicinal product

Conditions

Non-alcoholic Steatohepatitis (NASH)

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in serum alanine aminotransferase levels at week 48

  Measurement at week 0 and week 48

Study Arms (2)

Vitamin D3

EXPERIMENTAL

Drug: Vitamin D3; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Drug: Vitamin D3; Drug: Placebo

Interventions

Vitamin D3 DRUG

Vitamin D3, 2.100 IU/d p.o.

Placebo; Vitamin D3

Placebo DRUG

Placebo Tbl. p.o.

Placebo; Vitamin D3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with 25-OH vitamin D insufficiency
• Elevated alanine aminotransferase level
• Diagnosis of definite or possible steatohepatitis (NASH)

You may not qualify if:

• Cirrhosis, present liver disease other than NASH
• Serious diseases limiting life expectancy,
• Breast-feeding or pregnant women
• Unhealthy alcohol consumption
• Drug abuse or substitution therapy
• Use of vitamin preparations within the previous 6 months and during the study
• Weight loss \>5% within 12 months before study entry
• Newly diagnosed Diabetes mellitus requiring medical treatment within 12 months before study entry
• Use of anti-obesity drugs
• Previous or current hypercalcemia
• Chronic renal disease

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (2)

University Hospital Zurich, Gastroenterology and Hepatology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Andreas Geier, Prof. MD

  University Hospital Zurich, Division of Hepatology

  STUDY DIRECTOR

• Beat Muellhaupt, Professor, MD

  University Hospital Zurich, Division of Gastroenterology and Hepatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: April 4, 2012
• Study Start: January 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 25, 2016

Record last verified: 2016-10

Locations

CH (2)